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When shopping for a mortgage lender, it is absolutely imperative that you obtain more

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

than one quote. You should also ensure that every lender provides you with a Good Fa

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

th Estimate (GFE) to substantiate each offer. When reviewing these quotes, here are f

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ve important factors to think about:

1. Fixed or Adjustable

If a rate seems

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

very low compared to other offers, make sure that you are not getting an adjustable r

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

te when you requested a fixed mortgage. Brokers will often try to bait you with a low

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

adjustable rate.

2. Cash to Close

Look closely at how much cash each lender

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

is requiring you to bring to the closing table. Sometimes a slightly higher rate is f

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ne if it means that you need les money to close.

3. Escrow

Look carefully to

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

see if the quoted loan requires you to escrow your taxes and insurance. If so, make s

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

re your lender estimated the reserves that you will need to pay in order to set up th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e escrow account.

4. Origination Fees

Generally, the top line on a GFE will

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

how how many origination points you are paying the lender for obtaining the loan on y

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ur behalf. It will always be to your advantage to negotiate this amount. Remember, mo

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

t loan officers are paid on commission so they would rather make a little less than n

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

thing at all.

5. Complete GFE

Make sure all fees are disclosed that you will

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

be required to pay, i.e. origination fees, lender fees, processing fees, taxes, title

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

insurance, transfer tax, etc. Some brokers/lenders will attempt to leave off non-fixe

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

costs like taxes in an attempt to make their loan look more attractive.

These thoug

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ts should prepare you quite well when seeking out a fair and affordable mortgage loan

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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